Sonoma Orthopedic Products, Inc
26 catalogue numbers from 4.0mmx45mm Cancellous Bone Screw, Cannul, listed by Arthrex, Inc., United States, under Screw, Fixation, Bone. 31 manufacturers in China are registered for this product code.
31manufacturers in China registered for this device type
26catalogue numbers in this listing
46510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Record published | 2015-08-20 |
| Record revised | 2024-02-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 4 mm; length 40 to 60 mm |
| Distribution end date | 2020-07-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4.0mmx45mm Cancellous Bone Screw, Cannulated | Withdrawn | |
| 4.0mmx50mm Cancellous Bone Screw, Cannulated | Withdrawn | |
| 4.0mmx60mm Partially Threaded Cancellous Screw | Outer Diameter 4.0 mm | Withdrawn |
| 4.0mmx40mm Partially Threaded Cancellous Screw | Length 40 mm | Withdrawn |
| 4.0mmx50mm Partially Threaded Cannulated Cancellous Screw | Withdrawn | |
| 4.0mmx45mm Partially Threaded Cannulated Cancellous Screw Sterile | Withdrawn | |
| 4.0mmx45mm Partially Threaded Cannulated Cancellous Screw | Withdrawn | |
| 4.0mmx40mm Cancellous Bone Screw, Cannulated | Withdrawn | |
| 4.0mmx40mm Partially Threaded Cannulated Cancellous Screw Sterile | Withdrawn | |
| 4.0mmx50mm Partially Threaded Cancellous Screw | Withdrawn | |
| 4.0mmx40mm Cancellous Bone Screw | Withdrawn | |
| 4.0mmx55mm Partially Threaded Cannulated Cancellous Screw Sterile | Withdrawn | |
| 4.0mmx60mm Cancellous Bone Screw, Cannulated | Withdrawn | |
| 4.0mmx40mm Partially Threaded Cannulated Cancellous Screw | Withdrawn | |
| 4.0mmx50mm Partially Threaded Cannulated Cancellous Screw Sterile | Withdrawn | |
| 4.0mmx45mm Partially Threaded Cancellous Screw | Length 45 mm | Withdrawn |
| 4.0mmx50mm Cancellous Bone Screw | Withdrawn | |
| 4.0mmx55mm Cancellous Bone Screw, Cannulated | Withdrawn | |
| 4.0mmx55mm Partially Threaded Cancellous Screw | Length 55 mm | Withdrawn |
| 4.0mmx60mm Partially Threaded Cannulated Cancellous Screw Sterile | Withdrawn | |
| 2.7mm x 12mm Self-Tapping,”PRE-STERILE” Bone Screw | Withdrawn | |
| 4.0mmx55mm Cancellous Bone Screw | Withdrawn | |
| 4.0mmx60mm Partially Threaded Cannulated Cancellous Screw | Withdrawn | |
| 4.0mmx60mm Cancellous Bone Screw | Withdrawn | |
| 4.0mmx45mm Cancellous Bone Screw | Withdrawn | |
| 4.0mmx55mm Partially Threaded Cannulated Cancellous Screw | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260809 | 2026-06-25 |
| K254215 | 2026-05-08 |
| K243195 | 2025-01-10 |
| K241592 | 2024-08-31 |
| K240815 | 2024-06-13 |
| K220839 | 2022-09-19 |
| K210994 | 2021-06-01 |
| K203239 | 2020-12-30 |
| K193156 | 2020-02-10 |
| K191651 | 2019-11-06 |
| K190921 | 2019-10-30 |
| K183395 | 2019-04-17 |
| K183628 | 2019-03-26 |
| K182361 | 2018-12-18 |
| K170382 | 2017-05-11 |
| K151078 | 2015-05-15 |
| K143614 | 2015-01-16 |
| K132217 | 2013-11-25 |
| K112237 | 2011-09-02 |
| K103705 | 2011-03-18 |
| K071177 | 2007-06-29 |
| K063479 | 2006-12-13 |
| K061863 | 2006-10-19 |
| K062679 | 2006-09-27 |
| K061665 | 2006-07-25 |
| K060478 | 2006-05-19 |
| K053543 | 2006-04-03 |
| K053338 | 2006-01-26 |
| K052607 | 2005-11-07 |
| K051726 | 2005-09-27 |
| K050749 | 2005-05-12 |
| K050358 | 2005-04-15 |
| K050634 | 2005-03-21 |
| K043337 | 2004-12-14 |
| K041356 | 2004-11-04 |
| K041189 | 2004-11-04 |
| K032098 | 2003-10-07 |
| K031945 | 2003-09-22 |
| K022234 | 2002-10-03 |
| K020043 | 2002-04-02 |
| K010525 | 2001-05-23 |
| K003816 | 2001-03-09 |
| K981187 | 1998-07-01 |
| K945303 | 1996-01-25 |
| K945426 | 1995-04-14 |
| K915424 | 1993-02-09 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-10-01 | Class II | Employee error | Screws provided in the device package are 6 mm longer than intended. | 20 units | 2021-09-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.